CONSULTING SERVICES
Cleanrooms come in all shapes and sizes. Our desire is to help create successful cleanroom monitoring programs that are capable of mitigating risk and evaluating trends that lead to continuous improvements ensuring the safety of the product is not compromised.
We are here to help your cleanroom achieve a state of control and can provide consulting support to address:
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Training (gowning, cleanroom behavior, sample collection, etc.)
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Commissioning (cleanroom design, qualification, certification)
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Protocols and Risk Assessments
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Trending (data analysis)
Qualification and Certification Support
A successful environmental monitoring program begins with the appropriate qualification and certification activities that will lay the groundwork for routine testing.
EM Sample Collection and Analysis
Once a cleanroom is qualified and certified, a routine environmental monitoring program must be established. This program details the sampling type, frequency, and trending requirements to ensure that a cleanroom can be maintained in a state of control.
EM Utilities Sample Collection and Analysis
Most environmental monitoring qualifications are accompanied by utility qualifications, such as water for injection, USP water, reverse osmosis, and city water along with clean steam, compressed air, oxygen, carbon dioxide, and nitrogen.
Microbiology Support
A robust environmental monitoring program must address the need for microbial identifications, disinfectant efficacy studies, and biological indicators.
MODA-EM Paperless QC Micro Solution
MODA-EM™ software enables Alcami to incorporate one of our core values: data integrity. This comprehensive informatics platform combines data capture and error prevention with the flexibility to trend key quality and performance metrics.
